Exparel (DepoBupivacaine) shows promise in hernia repair

Biochemists at North Carolina State University have answered a fundamental question of how important bacterial proteins make life-and-death decisions that allow them to function, a finding that could provide a new target for drugs to disrupt bacterial decision-making processes and related diseases. In a study published this month in the journal Structure, the NC State

A Phase II trial of a single intraoperative administration of Exparel (DepoBupivacaine) resulted in significantly reduced pain with activity in the first 8 to 24 hours following surgery, when pain is generally greatest, compared to conventional treatment.

The results of the multicenter, randomized, double-blind study were presented in a poster at the Annual Postgraduate Assembly in Anesthesiology in New York City today, by lead investigator Richard Langford, MD, FRCA, Pain and Anaesthesia Research Centre, St. Bartholomew’s Hospital, London, UK.

Dr. Langford indicated that Exparel provided safe and well-tolerated analgesia with normal wound healing in all patients and noted that the study also showed:

Significant reductions in pain with activity in Exparel treated patients compared to active control

A positive trend toward lower opioid use in all Exparel groups compared to active control

More patients who received Exparel avoided opioids altogether, compared to active control.

In addition, the study demonstrated dose-proportional sustained plasma concentrations which support the prolonged local release of bupivacaine.

Presenting the results, Dr. Langford stated, “In addition to significantly lowering pain scores with activity during the 8 to 24 hours after administration, Exparel also showed trends of decrease in the number of patients using opioids and a decrease in total opioid consumption. This is an important finding as lowering opioid usage can spare patients from side effects, such as sedation, nausea, vomiting and respiratory depression, that can adversely affect their recovery.”

Exparel, a proprietary product of Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine HCL, a local anesthetic widely used for treating postoperative pain. The dose-escalating study evaluated the efficacy, safety, and pharmacokinetics of Exparel compared to bupivacaine HCL in 76 adult male patients (age ranges 48 to 63) in 10 hospitals in the UK and Australia. Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of Exparel or 100mg bupivacaine HCL around the surgical wound by infiltration immediately before closure.

There was a statistically significant reduction in pain intensity with activity across all Exparel doses during the first 8 to 24 hours after surgery compared to bupivacaine HCL (P<0.05). Each patient’s pain intensity score after surgery ranged from 21 - 31 across all Exparel groups compared to 45 - 48 for bupivacaine as measured by the Visual Analogue Scale (VAS) at 8, 12 and 24 hours.

The research also showed a trend toward lower opioid use in all Exparel groups compared to active control.

More patients in the Exparel groups completely avoided opioids 71% to 83% across doses, versus 50% for the bupivacaine groups.

Safety assessments reported in the poster found Exparel to be safe and well-tolerated. Wound healing was normal in all Exparel subjects with no significant differences between cohorts. Adverse events were generally mild to moderate with no significant differences between cohorts and no serious adverse events were attributed to the study drug.

Inguinal hernia repair is one of the most common operations in routine surgical practice. In the U.S., more than 600,000 procedures are performed annually with a majority performed on an out-patient basis, according to the National Center for Health Statistics.

Potential of Exparel

“The anesthesiology and surgical community recognizes the need for new approaches to postoperative pain management and welcomes the potential advance Exparel presents in overcoming limitations of conventional bupivacaine formulations,” said Ronald Burch, M.D., PhD, Chief Medical Officer, Pacira. “Exparel, currently in late Phase III clinical development, is being studied in several different types of surgical procedures where postoperative pain management is especially problematic and where the need for prolonged analgesia via a single administration can provide a significant improvement in pain relief, especially during the first 72-hours following surgery when pain is the most intense.”

Exparel is the latest product to benefit from Pacira’s proprietary sustained-release DepoFoam(R) technology. DepoFoam technology is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. It achieves this by encapsulating the drug in multivesicular liposomal particles which then release the drug over a desired period of time without altering the drug molecule. DepoFoam is a proven technology that is already used in two commercially available products in the U.S. and Europe.

Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL (DepoBupivacaine) for prolonged postoperative analgesia. Results from the studies in hemorrhoidectomy and in total knee arthroplasty (TKA) are expected

A review of more than 4 million insured patients with private coverage and Medicaid, published in the The Journal of Pain showed that rates of opioid use did not differ widely between non-cancer pain conditions but there were higher rates of opioid use among Medicaid patients. In this study, researchers examined general trends in prescription

TheraQuest Biosciences, Inc. a development stage pain management company today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (”IND”) application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using Securel, TheraQuest’s proprietary abuse deterrent technology. Najib Babul, PharmD, Chief Executive Officer of

The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. “This approval offers health care professionals an additional choice for treating moderate to

Severely obese patients who have lost significant amounts of weight by changing their diet and exercise habits may be as successful in keeping the weight off long-term as those individuals who lost weight after bariatric surgery, according to a new study published online by the International Journal of Obesity. While weight loss and maintenance were